Method of forming flexible ampoules



July 8, 1969 R. H. soTo METHOD OF FORMING FLEXIBLE AMPOULES Filed May 8,1967 FIG. 6

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INVENTOR: RICARDO HURTADO SOTO l BY v ATT'YS United States Patent O U.S.Cl. 53--14 8 Claims ABSTRACT F THE DISCLOSURE A method of formingflexible ampoules. A longitudinally folded web equipped withlongitudinal gussets along the upper and lower edges thereof islongitudinally advanced toward a filling spout. A pair of films islongitudinally advanced so that the web is interposed between the films.The surface of the films adjacent the web may be coated with anantioxidant or an antiseptic. The films and web are transversely sealedat spaced longitudinal points, and the lower edges of the film arelongitudinally sealed below the lower web gusset. The sides of the upperweb gusset pass opposite sides of the filling spout, which reciprocatesfrom a first position to a filling position, thereby perforating theweb. The spout reciprocates once between adjacent transverse seals.Thereafter, the upper edges of the web and films are longitudinallysealed.

Related application This application is a eontinuation-in-part of myprior co-pending application entitled Liquid Container and Method, Ser.No. 405,551, filed Oct. 21, 1964, now abandoned.

Background of the invention This invention relates to a container, andfinds particu- The inventive method provides a container which may befilled with a measured amount of medicament. The thin material of theampoule is readily pierced by a needle to aspirate the medicament, andthe ampoule is provided with a gusset to facilitate insertion of `theneedle, Before insertion of the needle the medicament is protected by anouter covering which may be coated with an antioxidant or an antiseptic.After the contents of the ampoule are aspirated, the relativelyinexpensive ampoule may be disposed of.

Description of the drawing FIG. l is a perspective view of a coil orroll of tubing which is employed in the inventive method;

FIG. 2 is a sectional view of the tubing of FIG. 1;

FIG. 3 is a schematic view showing some of the steps of forming theampoules;

FIG. 4 is a perspective view, partially in schematic form, showingfurther steps in forming the ampoules;

FIG. 5 is a fragmentary sectional view taken along the line 5-5 of FIG.4;

3,453,797 Patented July 8, 1969 FIG. 6 is a sectional view similar toFIG. 5 showing the filling spout in the filling position;

FIG. 7 is a schematic view of the tubing of FIG. 1 in one step of theinventive method; and

FIG. 8 is a section view of a completed ampoule.

Description of the preferred embodiment Referring to FIG. 8, the numeral10 designates generally a flexible ampoule formed according to theinventive method. The ampoule 10 includes `an inner liquidfilled packet11, which is encased in an outer covering 12. An oily protective layer13 of antioxidant or antiseptic may be dispersed between the packet 11and the outer covering 12. An antioxidant may be used if it is desiredto improve the oxygen and water vapor barrier characteristics of theampoule, and an antiseptic may be used if it is desired to improve itssterile characteristics. Many oil and grease soluble antioxidants aresuitable, such as propylgallate or S-acenaphthenol. Similarly, many oiland grease soluble antiseptics may be used. Derivatives of the phenolgroup such as hexilresorcin have been found particularly suitable.

One end of the ampoule is formed by sealing the outer covering 12 as at14, and the other end of the ampoule is formed by sealing the outercovering and one end of the packet 11 as at 15. The packet 11 is seen tobe provided with a gusset or fold as at 16 at one end thereof, and thegusset is advantageously provided by sides of unequal height such aslong side 16a and short side 16b.

When it is desired to remove the contents of the ampoule, the nurse orphysician tears the sealed edge 14 of the outer covering to expose the-gusset 16 of the inner packet. A hypodermic syringe is then insertedinto the gusset to perforate the packet 11 so that the contents may bewithdrawn. The unequal sides 16a and 16b of the gusset facilitateinsertion of the hypodermic syringe into the gusset.

For the purpose of developing the ampoule 10, a continuous web or lengthof tubing such as that designated generally by the number 17 of FIG. 1is employed. It will be seen that the tubing 17 provides confrontingfaces 18 and 19 interconnected along the bottom edge by gusset 16 andalong the upper edge by gusset 20. Both of the gussets may be providedby folding the tubing along spaced parallel lines. The sides of gusset16 are lseen to be of unequal height-side 16a being slightly longer thanside 16b.

The actual sequence of operations in f'orming and filling the ampoulescan be seen by reference to FIGS. 3 and 4. The plastic tubing 17, whichis advantageously thermoplastic in nature, such as polyethylene, isunrolled from a suitable unwind stand 21 with gusset 20 disposeduppermost. In other Words, the axis of the roll of tubing is disposedvertically. Means for unwinding the roll of tubing 17 and advancing itlongitudinally may be provided in the form of draw rolls 22 and 23 (FIG.4).

A first outer film 12a is unrolled from unwind stand 24, and a secondouter film 12b is unrolled from unwind stand 25. Films 12a and 12b arealso advanced by draw rolls 22 and 23, land are positioned by idlerrollers 26 and 27 adjacent the plastic tubing 17. The films may be madeof a transparent, non-elastic material which is relatively impervious tooxygen and moisture, such as ethyl vinyl acetate, polyvinylidenechloride (Saran), or the like. It is desirable that at least one of thefilms be transparent in order to permit visual observation of thecontents of the ampoule, but one of the films may be metallic foil orother opaque material which provides better protection for the ampoulecontents.

Enroute to the idler rollers the sides of the films 12a and 12b areadvantageously coated with a layer 13 of protective material. Theprotective material may be either an antioxidant if it is desired toimprove the oxygen and water vapor barrier characteristics of theampoule, or it may be an antiseptic if it is desired to improve thesterile characteristics of the ampoule. The lms may be coated by anysuitable means, and FIG. 3 illustrates two alternative means. Film 12ais drawn through reservoir 28 under the urging of roller 29, and film12b is covered by applicator 30, which is urged against the film byspring 31. The layer of protective material is not necessary for alltypes of medicine, however.

Referring now to FIG. 4, the tubing 17 and the films 12a and 12b formstrip S which is drawn through draw rollers 22 and 23 and advancedtoward sealing element 32. The width of the films 12a and 12b is suchthat their bottom edges 12e extend below the bottom of the longer side16a of gusset 16 of the web, and the top edge of the films terminate atabout the top of the web. Sealing element 32 heat seals the lower edgesof the films 12a and 12b below the bottom of gusset side 16a to formbottom seal 14. Sealing element 32 also transversely seals the films 12aand 12b and the plastic tubing at spaced longitudinal points as at 33 toform discrete ampoules or containers 34. Each ampoule 34 is also sealedlongitudinally adjacent the top thereof as at 35 by sealing element 32.Longitudinal seals 35 are positioned below the upper edge of the strip Sand extend only part way across the mouth of each packet 34 to providean unsealed portion 36. The transverse seals 33 also terminate below theupper edge of the strip S so that at least a portion of upper gusset 20of the plastic tubing remains unsealed.

The discrete ampoules 34 are advanced toward transverse cutter 37 whichcuts the strip S approximately centrally of each transverse seal 23between the upper and lower longitudinal seals 35 and 14' to form slits38 between adjacent ampoules 34. The transverse cutter 37 bisects thetransverse seals 33 so as to utilize one half of the seal as the sealfor the trailing edge of a first container and the leading edge of asubsequent container.

The strip S is then advanced toward a filling spout 39 which ispositioned within gusset 20' of the web. The sides of gusset 20 passopposite sides of the filling spout 39, and the web is guided thereby.When an opening 36 between adjacent upper longitudinal seals 35 ispositioned below the filling spout, the filling spout reciprocates fromthe guide position shown in solid in FIG. 4 to the filling positionshown in dotted outline. As the filling spout is lowered through thegusset it pierces the web and enters the ampoule 34. When the desiredamount of medicament has been injected into the ampoule, the fillingspout is withdrawn to the guide position, and the opening 36 and thehole made by the filling spout is 'sealed by a sealing element 40. Aseach ampoule 34 is filled with medicament, the pressure causes the sidesof the packet to assume an arched configuration as at 41. Rather thanutilizing a web of plastic tubing that has a closed upper edge providedby gussets 20, the upper edge'. may be open to pass the filling spoutand thereafter sealed by sealing element 40.

It will be appreciated that a frame (not shown) may be provided forsupporting the various means described in connection with the operationpictured in FIGS. 3 and 4. The strip S may either be advancedintermittently to permit the various sealing and filling operations tobe performed while the strip is stationary, or the strip may be advancedcontinuously and the sealing and filling means may move on the frame. Ifdesired, the strip may be equipped with signalling means for activatingthe various means by way of a photocell as described in my priorapplication, Ser. No. 405,551, filed Oct. 21, 1964. During the time thatthe strip is in the apparatus it may advantageously be subjected toultra violet or gamma rays from source 42.

As the strip S is advanced beyond sealing element 40, the connectionsbetween the individual ampoules 34 may be severed to provide singleampoules, or a plurality of ampoules may be maintained in the joinedcondition and shipped as a unit. When an individual ampoule is to beused, it may be torn from the strip.

When the contents of the ampoule are desired to be withdrawn, the nurseor physician tears the sealed end 14 (FIG. 8) to expose the gusset 16. Ahypodermic syringe may then be inserted into gusset 16 to perforate theinner packet 11. If the protective layer 13 is an antiseptic, the needleis lubricated with the antiseptic when it passes through the gusset,thereby preserving the antiseptic quality of the medicament.

The filling spout 39 may inject either liquid or powdered medicamentinto the ampoule. A powdered medicament can be diluted in the ampoule byinjection of a suitable solvent by a syringe, and when the solution isready, it may be aspirated by the syringe without the introduction ofair.

While in the foregoing specification a detailed description of anembodiment of the invention was set down for the purpose of explanation,many variations of the details herein given may be made by those skilledin the art without departing from the spirit and scope of the invention.

I claim:

1. In a method of forming flexible ampoules, the steps of longitudinallyadvancing a longitudinally folded web, said web being provided with alongitudinal gusset along the lower edge thereof, advancing a pair offilms in covering relationship with the sides of said web, transverselysealing said films and said web at longitudinally spaced pointstherealong, the transverse seals extending only part way across thewidth of said web to terminate short of the upper edge `of the web,longitudinally sealing the lower edges of said films below the loweredge of said web, advancing said web and said films so that confrontingfaces of said folded web pass opposite sides of a filling spout, saidspout being interposed between said confronting faces, and thereafterlongitudinally sealing said films and said web adjacent the upper edgeof said web to develop a plurality of liquid-tight containers defined bysaid web.

2. The method of claim 1 including the step of transversely cutting saidweb and said film generally centrally of said transverse sealsintermediate the upper and lower edges.

3. The method of claim 1 in which said web is provided with a secondlongitudinal gusset along the upper edge thereof, the sides of saidsecond gusset providing said confronting faces, said spout reciprocatingfrom a guide position above the bottom of the second gusset to a fillingposition below the second gusset bottom, said web being perforated bysaid spout in the filling position.

4. The method of claim 1 in which the surfaces of said films adjacentsaid web are coated with an antioxidant.

5. The method of claim 1 in which the surfaces of said films adjacentsaid web are coated with an antiseptic.

6. In a method of forming flexible ampoules, the steps of longitudinallyadvancing a longtudinally folded web, said web being provided with afirst longitudinal gusset along the lower edge thereof and a secondlongitudinal gusset along the upper edge thereof, advancing a pair offilms in covering relationship with the sides of said web, transverselysealing said films and said web at longitudinally spaced pointstherealong, the transverse seals extending only part Way across thewidth of said web to terminate short of the upper edge of the web,longitudinally sealing the lower edges of said films below the loweredge of said web, transversely cutting said web and said films generallycentrally of said transverse seals intermediate the web upper and loweredges, advancing said web and said films toward a filling spout, saidspout being positioned within said second gusset, moving said spout 5downwardly to perforate said web between said transverse seals,introducing a medicament through said filling spout, withdrawing saidspout from web, and thereafter longitudinally sealing said lms and saidweb `adjacent the upper edge of said web to develop a plurality of 5liquid-tight containers defined by said web.

7. The method of claim 6 in which the surfaces of said lms adjacent saidweb are coated with an antioxidant.

8. The method of claim 6 in which the surfaces of said lm adjacent saidweb are coated with an antiseptic.

6 References Cited UNITED STATES PATENTS 2,272,251 2/1942 Robinson53-180 X 3,386,604 6/1968 Fields 53--29 X THERON E. CONDON, PrimaryExaminer. E. F. DESMOND, Assistant Examiner.

U.S. Cl. X.R. 53-27, 29

